UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056056 |
|---|---|
| Receipt number | R000064058 |
| Scientific Title | Success factors for multiplex molecular testing by EBUS-GS |
| Date of disclosure of the study information | 2024/11/05 |
| Last modified on | 2024/11/06 10:20:39 |
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Basic information
Public title
Success factors for multiplex molecular testing by EBUS-GS
Acronym
Success factors for multiplex molecular testing by EBUS-GS
Scientific Title
Success factors for multiplex molecular testing by EBUS-GS
Scientific Title:Acronym
Success factors for multiplex molecular testing by EBUS-GS
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We investigated factors that enable collection of samples necessary for multigene testing using EBUS-GS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluated whether pathologists could submit samples to ODxTT or AmoyDx multi-gene testing.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study included 59 cases in which a pathological diagnosis of non-small cell lung cancer was obtained using EBUS-GS in the respiratory medicine department of our hospital between August 2021 and December 2023, and in which a pathologist at our hospital reviewed whether or not to submit a multi-gene test.
Key exclusion criteria
none
Target sample size
59
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Kajiwara |
Organization
Matsuyama Red Cross Hospital
Division name
Department of Respiratory Medicine
Zip code
7908524
Address
1 Bunkyo, Matsuyama, Ehime, Japan.
TEL
0899241111
respiratory24@outlook.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Kajiwara |
Organization
Matsuyama Red Cross Hospital
Division name
Department of Respiratory Medicine
Zip code
7908524
Address
1 Bunkyo, Matsuyama, Ehime, Japan.
TEL
0899241111
Homepage URL
respiratory24@outlook.jp
Sponsor or person
Institute
Matsuyama Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Matsuyama Red Cross Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matsuyama Red Cross Hospital
Address
1 Bunkyo, Matsuyama, Ehime, Japan.
Tel
0899241111
respiratory24@outlook.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
https://www.matsuyama.jrc.or.jp/
Publication of results
Published
Result
URL related to results and publications
https://www.matsuyama.jrc.or.jp/
Number of participants that the trial has enrolled
59
Results
In total, 30 (51%) samples were deemed submittable, whereas 29 were considered non-submittable.Logistic regression analysis demonstrated a significant association between a biopsy frequency of seven or more and the successful collection of samples necessary for multiplex molecular testing.
Results date posted
| 2024 | Year | 11 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The sample included 36 male patients, with a median age of 75 years. The distribution of stages (I/II/III/IV) was 24/6/9/20 that included 33 cases of adenocarcinoma. The median tumor size was 30 mm, and 46 patients showed bronchial signs on CT. Bronchoscopy revealed a median biopsy frequency of five times, with positive ultrasound findings observed in 44 cases.
Participant flow
none
Adverse events
none
Outcome measures
Whether a pathologist can submit AmoyDX Lung Cancer Multigene PCR Panel or Oncomine TMDx Target Test
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study included 59 cases in which a pathological diagnosis of non-small cell lung cancer was obtained using EBUS-GS at our hospital between August 2021 and December 2023, and in which a pathologist reviewed whether or not to submit the AmoyDX Lung Cancer Multi-Gene PCR Panel or Oncomine TMDx Target Test.
Management information
Registered date
| 2024 | Year | 11 | Month | 05 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064058
